Endotracheal Intubation During SurgeryBIPETTNCT01682486
BIP ETT Clinical Tolerability, Safety and Performance Study
A study testing BIP ETT (Bactiguard) and Standard ETT in people with Endotracheal Intubation During Surgery and Hospital Acquired Infections, run by Bactiguard AB at 1 site in Sweden.
Trial summary
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation During Surgery, Hospital Acquired Infections
- What is being tested?
- BIP ETT (Bactiguard) and Standard ETT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult men and women >=18 years of age
- are, in opinion of the investigator able to communicate with and understand the trial personnel and comply with the requirements of the trial (e.g. fill in questionnaire)
- requiring endotracheal intubation >=3 h for elective surgery of upper gastrointestinal tract with a tube size of 7 or 8
- has signed informed consent
Who cannot join
- known transmissive blood disease
- known multiresistant bacterial colonization
- current and continuous treatment by immunomodulating therapies - e.g. systemic (or inhalation) use of cortisone or NSAIDS
- ongoing respiratory infection
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital
Huddinge, Stockholm County, SE-141 86
About this study
Official title: Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.
- Being tested
- BIP ETT (Bactiguard), Standard ETT
- Keywords
- Medical device, Endotracheal Tube(s), ETT, Bactiguard Coated ETT, Tolerability, Safety, Performance, Bacterial colonization on ETT surface, Hospital Acquired Infections, HAI, Ventilator Associated Pneumonia, VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIP ETT (Bactiguard)Device
Also called BIP Endotracheal tube, Bactiguard coated ETT, Bactiguard coated Endotracheal tube
Ventilation of surgery patients during anesthesia using BIP ETT
Standard ETTProcedure or surgery
Also called ETT, Endotracheal tube, Standard Endotracheal tube, Uncoated ETT
Ventilation of surgery patients during anesthesia using standard ETT
| Study group | Role | What they receive |
|---|---|---|
| BIP ETT, Bactigaurd coated endotracheal tube | Experimental | Not described Receives: Device: BIP ETT (Bactiguard) |
| Standard ETT, un-coated endotracheal tube | Placebo comparator | Not described Receives: Procedure: Standard ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos.
Measured: Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours
Secondary outcomes (2)
Overall assessment of safety (device related adverse events and any problems in post postoperative course)
Measured: Participants will be followed on the surgery day and the day after surgery
Overall assessment of device performance
Recording of any device related problems experienced by the physician/health care personnel
Measured: The performance will be followed during surgery of an expected average duration of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Intubation During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bactiguard AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sigridur Kalman, MD PhD Prof, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682486
- Sponsor's protocol ID
- 1842-2026-CDOC
- Acronym
- BIPETT
- Status last verified
- Jul 2014
- First submitted
- 30 Aug 2012
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bjorling G, Johansson D, Bergstrom L, Jalal S, Kohn I, Frostell C, Kalman S. Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study. BMC Anesthesiol. 2015 Dec 1;15:174. doi: 10.1186/s12871-015-0156-z.
PubMed 26625869
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating
- ClinicalTrials.gov ID
- NCT01682486
- Acronym / sponsor ID
- BIPETT / 1842-2026-CDOC
- Keywords
- Medical device, Endotracheal Tube(s), ETT, Bactiguard Coated ETT, Tolerability, Safety, Performance, Bacterial colonization on ETT surface, Hospital Acquired Infections, HAI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bactiguard ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIP ETT, Bactigaurd coated endotracheal tube | Experimental | Device: BIP ETT (Bactiguard) |
| Standard ETT, un-coated endotracheal tube | Placebo comparator | Procedure: Standard ETT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult men and women >=18 years of age
- are, in opinion of the investigator able to communicate with and understand the trial personnel and comply with the requirements of the trial (e.g. fill in questionnaire)
- requiring endotracheal intubation >=3 h for elective surgery of upper gastrointestinal tract with a tube size of 7 or 8
- has signed informed consent
Key exclusion criteria (4 listed)
- known transmissive blood disease
- known multiresistant bacterial colonization
- current and continuous treatment by immunomodulating therapies - e.g. systemic (or inhalation) use of cortisone or NSAIDS
- ongoing respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIP ETT (Bactiguard)Also: BIP Endotracheal tube, Bactiguard coated ETT, Bactiguard coated Endotracheal tubeVentilation of surgery patients during anesthesia using BIP ETT | Device | BIP ETT, Bactigaurd coated endotracheal tube |
| Standard ETTAlso: ETT, Endotracheal tube, Standard Endotracheal tube, Uncoated ETTVentilation of surgery patients during anesthesia using standard ETT | Procedure or surgery | Standard ETT, un-coated endotracheal tube |
Primary outcome
Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos.
Time frame: Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours
2 secondary outcomes
Overall assessment of safety (device related adverse events and any problems in post postoperative course)
Time frame: Participants will be followed on the surgery day and the day after surgery
Overall assessment of device performance
Time frame: The performance will be followed during surgery of an expected average duration of 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Results publication: PubMed 26625869Bjorling G, Johansson D, Bergstrom L, Jalal S, Kohn I, Frostell C, Kalman S. Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study. BMC Anesthesiol. 2015 Dec 1;15:174. doi: 10.1186/s12871-015-0156-z.
- Individual participant dataSharing planned: No
Related trials for Endotracheal Intubation During Surgery
RecruitingPhase 3
Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation and Bolus Maintenance in Adults
Neuromuscular Blockade
RecruitingObservational study
VENtilation Modalities During Transport of PostoperatIve CRITically Ill Patients to the ICU
Respiration, Artificial, Positive-Pressure Respiration
Enrolling by invitationPhase 3
Efficacy and Safety of HRS-9190 in General Anesthesia
Adult Participants Requiring Tracheal Intubation Under General Anesthesia for Elective Surgery
Not yet recruitingObservational study
A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Spontaneous Breathing and the Double-lumen Bronchial Intubation on the Brain Health During the Perioperative Period
Brain Health
RecruitingPhase 4
Dexmedetomidine vs Lignocaine for Reducing Intubation-Induced Hemodynamic Responses in Cardiac Surgery: A Randomized Controlled Trial
Laryngoscopic Stress Response, Dexmedetomidine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigridur Kalman, MD PhD Prof principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIP ETT (Bactiguard) and Standard ETT in people with Endotracheal Intubation During Surgery and Hospital Acquired Infections, run by Bactiguard AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos. (time frame: Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01682486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.